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The EU Packaging and Packaging Waste Regulation (EU 2025/40) now applies to medical device and IVD packaging. Here is what manufacturers must do, and where limited exemptions apply.

This EU legal text is a Commission Implementing Decision (EU) 2025/2078, adopted on 17 October 2025, which updates the list of harmonised standards under the Medical Device Regulation (MDR, Regulation (EU) 2017/745). It specifically adds new standards for surgical clothing and drapes, medical face masks, and sterilisers for medical purposes. 📌 What the Decision Does • Updates Implementing Decision (EU) 2021/1182: This earlier act listed harmonised standards supporting MDR.

📜 What is a Certificate of Free Sale? • A Certificate of Free Sale (CFS) is an official document issued under Article 60 of the EU Medical Device Regulation (MDR 2017/745). • It confirms that a medical device: • Bears the CE marking • Meets EU regulatory standards • Is legally placed on the EU market 🌍 Why is it Needed? • Export Requirement: Many non‑EU countries require proof that a product is freely sold in its country of origin before granting import or registration

Many potential customers frequently inquire about whether it's possible to change their authorized representative. Yes, this is allowed under MDR 2017/745 Article 12. Article 12 states: "An agreement between the manufacturer and both the outgoing and incoming authorised representatives must delineate the process for transitioning representatives. The agreement should specify: (a) the commencement and conclusion dates of each representative's mandate; (b) the duration for whi

The new revision is ISO 10993‑1:2025, published in November 2025. It is the 6th edition of the biocompatibility cornerstone standard and introduces a stronger risk‑based, lifecycle‑oriented approach. 🔑 Key Updates in ISO 10993‑1:2025 Risk Management Integration: Biological evaluation must now be fully integrated into the ISO 14971 risk management framework. Testing is no longer a checklist; manufacturers must justify test selection or omission with scientific rationale. Expo

🆕 What’s New in the 2025 Amendment Updated Symbol for Authorized Representative The familiar “EC REP” symbol has been revised to “EU REP”, making it non-country-specific and more globally applicable. Defined Term for Authorized Representative A clearer definition was added to align with international regulatory frameworks. Use of Country Codes The symbol may now include two- or three-letter country codes (e.g., CH for Switzerland), though not all jurisdictions recognize t

The FDA’s Quality Management System Regulation (QMSR) is the updated framework that will replace the traditional Quality System Regulation (QSR) under 21 CFR Part 820. This change will officially take effect on February 2, 2026, marking a significant transformation in the way medical device manufacturers are required to manage their quality systems. 🧭 What Is QMSR? This is a modernized regulation that brings U.S. requirements in line with ISO 13485:2016, the global standard

The European Database on Medical Devices (EUDAMED) is revolutionizing the way medical devices are regulated and monitored across the EU. This post explains what EUDAMED is, its key components, and why manufacturers and authorized representatives must prioritize accurate registration and data management to stay compliant. Centralized Information Hub: EUDAMED consolidates data on medical devices, economic operators, clinical investigations, vigilance, and market surveillance in